The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

Mead Johnson Nutrition22 sites in 1 country348 target enrollmentJuly 2013

ConditionsGrowth of Term Infants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth of Term Infants
Sponsor: Mead Johnson Nutrition
Enrollment: 348
Locations: 22
Primary Endpoint: Body weight measured at each study visit
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

April 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mead Johnson Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Singleton, 12-16 days of age at randomization
•Term infant with birth weight of a minimum of 2500 grams
•Solely formula fed
•Signed Informed Consent and Protected Health Information

Exclusion Criteria

•History of underlying metabolic or chronic disease or immunocompromised
•Feeding difficulties or formula intolerance

Outcomes

Primary Outcomes

Body weight measured at each study visit

Time Frame: 3.5 months

Secondary Outcomes

Medically-confirmed adverse events collected throughout the study period(3.5 months)
Recall of infant formula intake at each study visit(3.5 months)
Recall of stool consistency measured at each study visit(3.5 months)
Parental Study Product Assessment Questionnaire completed at Study Visit 2(once)
Head circumference measured at each study visit(3.5 months)
Recall of gastrointestinal tolerance measured at each study visit(3.5 months)
Body length measured at each study visit(3.5 months)